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510(k) K981524

PRILANE by Gresco Products, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1998
Date Received
April 28, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

Other clearances by Gresco Products, Inc.

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  • K901973 — CP-3 DENTAL POLISHING MATERIAL (June 1, 1990)
  • K854495 — GRESCO N.P. DENTAL ALLOY (December 27, 1985)
  • K854494 — CERAM-ETCH (December 23, 1985)

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